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Period Ending March 21, 2008
ALZHEIMER’S: RESEARCHERS IDENTIFY POTENTIAL NEW DRUG TARGET
Researchers at the University of California, San Diego and colleagues have demonstrated in mice a way to reduce the overproduction of a peptide associated with the Alzheimer’s disease. The study, published in the online edition of the Journal of Biological Chemistry, showed substantial improvement in memory in an animal model of Alzheimer’s disease. The findings point to possible new treatments for the neurodegenerative disease. A hallmark sign of Alzheimer’s disease is the accumulation of amyloid plaque deposits composed primarily of the neurotoxic beta-amyloid peptide, which is believed to be a major factor in the cause of the disease. The amyloid peptides are cut out from a larger protein called the amyloid precursor protein, and bind together to form plaques in brain regions responsible for memory. One drug strategy to fight Alzheimer’s disease is to reduce production of the peptides. The researchers discovered two chemical compounds they said inhibit a new enzyme target, leading to reduced production of beta-amyloid.
Researchers at the University of California, San Diego and colleagues have demonstrated in mice a way to reduce the overproduction of a peptide associated with the Alzheimer’s disease. The study, published in the online edition of the Journal of Biological Chemistry, showed substantial improvement in memory in an animal model of Alzheimer’s disease. The findings point to possible new treatments for the neurodegenerative disease. A hallmark sign of Alzheimer’s disease is the accumulation of amyloid plaque deposits composed primarily of the neurotoxic beta-amyloid peptide, which is believed to be a major factor in the cause of the disease. The amyloid peptides are cut out from a larger protein called the amyloid precursor protein, and bind together to form plaques in brain regions responsible for memory. One drug strategy to fight Alzheimer’s disease is to reduce production of the peptides. The researchers discovered two chemical compounds they said inhibit a new enzyme target, leading to reduced production of beta-amyloid.
Doctors may one day be able to detect early stages of colon cancer without a biopsy, using a new technique developed by researchers at the Stanford University School of Medicine. This imaging technology allows detection of cancers in the body in real time. The researchers predicted similar techniques will eventually be able to find a wide range of cancers, monitor cancer treatment, and deliver chemotherapies directly to cancerous cells in the colon, stomach, mouth, and skin. The study, published online in Nature Medicine, showed the researchers were able to identify which cells were cancerous while they were still in the body. They found a short protein that sticks to colon cells in the early stages of cancer. Before screening a person, the scientists spray that short protein—with a fluorescent beacon attached to it—into the colon. The protein then gloms on to any cancerous cells and creates an easily visible fluorescent patch. They then used a miniaturized microscope to peer inside the colon and look for those telltale spots. Not only did the researchers see fluorescent patches, they could make out the individual cancerous cells. The researchers said the real-time screening could also be used as a way of assessing whether a chemotherapy regimen is working. If a tumor responds to a given chemotherapy, changes in the cells might be visible immediately. That response could allow doctors to switch patients to a new, more effective treatment if the first one results in no improvement.
ALZHEIMER’S: DRUG STABILIZES BEHAVIORAL SYMPTOMS IN AD
San Francisco-based Medivation said that clinical results from its first pivotal trial of its drug Dimebon showed that behavioral symptoms were stabilized in patients with mild-to-moderate Alzheimer's disease over a one-year period, resulting in decreased caregiver distress. Benefits of Dimebon were seen across most behavioral symptoms and were most prominent in the symptoms of depression, apathy, hallucinations, irritability, and motor disturbance. The data were presented during a poster session on new research topics at the annual meeting of the American Association for Geriatric Psychiatry at the University of California, Los Angeles. These findings are noteworthy because behavioral symptoms are among the most difficult aspects of Alzheimer's disease that caregivers face, and often result in institutionalization of patients. Medivation is planning to initiate a second, confirmatory, pivotal late-stage trial of Dimebon in mild-to-moderate Alzheimer's disease in the second quarter of 2008 with the goal of completing the trial and applying for U.S. and European marketing approval in 2010.
San Francisco-based Medivation said that clinical results from its first pivotal trial of its drug Dimebon showed that behavioral symptoms were stabilized in patients with mild-to-moderate Alzheimer's disease over a one-year period, resulting in decreased caregiver distress. Benefits of Dimebon were seen across most behavioral symptoms and were most prominent in the symptoms of depression, apathy, hallucinations, irritability, and motor disturbance. The data were presented during a poster session on new research topics at the annual meeting of the American Association for Geriatric Psychiatry at the University of California, Los Angeles. These findings are noteworthy because behavioral symptoms are among the most difficult aspects of Alzheimer's disease that caregivers face, and often result in institutionalization of patients. Medivation is planning to initiate a second, confirmatory, pivotal late-stage trial of Dimebon in mild-to-moderate Alzheimer's disease in the second quarter of 2008 with the goal of completing the trial and applying for U.S. and European marketing approval in 2010.
Mountain View, California-based Perlegen Sciences said that it has formed a personalized medicine collaboration with an undisclosed electronic medical records provider to identify and develop genetic markers to help predict how patients are likely to respond to specific medical treatments. Perlegen and its partner will mine data from the records provider’s growing information warehouse, which currently contains clinical treatment and outcome data on roughly 4 million patients, to enable the identification of subsets of patient records which meet highly specific criteria. Working via each patient’s individual care provider, Perlegen will seek to obtain DNA from these selected patients to help physicians address various medical situations in which genetically-based predictions about treatment response may help significantly improve patient care. The company said making personalized medicine a reality relies on the discovery and validation of genetic markers to help predict how patients might respond to specific medical treatments. The company said discovery of such markers has been long delayed by the lack of appropriate DNA sample sets linked with rich clinical information.
DRUG COCKTAILS: RESEARCHERS DEVELOP METHOD TO IDENTIFY OPTIMAL MIX OF DRUGS
University of California, Los Angeles researchers have developed a feedback control scheme that they said can search for the most effective drug combinations to treat a variety of conditions, including cancers and infections. The discovery could play a significant role in facilitating new clinical drug-cocktail trials. Drug cocktails have been important in fighting such diseases as HIV and cancer, but it has been a challenge for clinical researchers to determine the optimal dose of individual drugs used in combination. For example, a researcher testing 10 different concentrations of six drugs in every possible arrangement would be faced with 1 million potential combinations. Often, drugs that might not be effective in combating diseases individually do much better in combination. Their approach, described in a study published online in the journal Proceedings of the National Academy of Sciences, provides an optimization method that they said overcomes a major roadblock of too many choices and too many combinations to sort through.
University of California, Los Angeles researchers have developed a feedback control scheme that they said can search for the most effective drug combinations to treat a variety of conditions, including cancers and infections. The discovery could play a significant role in facilitating new clinical drug-cocktail trials. Drug cocktails have been important in fighting such diseases as HIV and cancer, but it has been a challenge for clinical researchers to determine the optimal dose of individual drugs used in combination. For example, a researcher testing 10 different concentrations of six drugs in every possible arrangement would be faced with 1 million potential combinations. Often, drugs that might not be effective in combating diseases individually do much better in combination. Their approach, described in a study published online in the journal Proceedings of the National Academy of Sciences, provides an optimization method that they said overcomes a major roadblock of too many choices and too many combinations to sort through.
CANCER: RESEARCHERS IDENTIFY TWO PROTEINS IN TELOMERASE, WHICH ENABLES CANCER
Researchers at Stanford University School of Medicine have identified two new proteins that make up the telomerase complex and have a lead on several more. This is the first significant step toward understanding the makeup of telomerase since 1999, the researchers said. The discovery of these two proteins provides new targets for cancer treatments. Telomerase is a protein conglomerate that has been implicated in some critical areas of medicine including cancer, aging, and keeping stem cells healthy. It is best known for its role in maintaining the cell's genetic material, the chromosomes. Every time a person's cell divides, it makes a second copy of the 46 chromosomes, and then sends one copy to each of the two resulting cells. As that copying process proceeds, each replication snips a bit off the protective tips of the chromosomes, called telomeres. Those ever-shortening chromosomes are one reason cells age. After a lifetime of cells dividing, the telomeres dwindle down to a length that eventually triggers the cell to stop replicating altogether or die. Cancerous cells overcome that lifespan limitation by making telomerase, which repairs those snipped chromosome ends. Without shortening, the cells can divide forever. Telomerase is normally active in fetal cells, and then shortly after birth it is turned off in all cells except normal tissue stem cells and some immune cells.
Researchers at Stanford University School of Medicine have identified two new proteins that make up the telomerase complex and have a lead on several more. This is the first significant step toward understanding the makeup of telomerase since 1999, the researchers said. The discovery of these two proteins provides new targets for cancer treatments. Telomerase is a protein conglomerate that has been implicated in some critical areas of medicine including cancer, aging, and keeping stem cells healthy. It is best known for its role in maintaining the cell's genetic material, the chromosomes. Every time a person's cell divides, it makes a second copy of the 46 chromosomes, and then sends one copy to each of the two resulting cells. As that copying process proceeds, each replication snips a bit off the protective tips of the chromosomes, called telomeres. Those ever-shortening chromosomes are one reason cells age. After a lifetime of cells dividing, the telomeres dwindle down to a length that eventually triggers the cell to stop replicating altogether or die. Cancerous cells overcome that lifespan limitation by making telomerase, which repairs those snipped chromosome ends. Without shortening, the cells can divide forever. Telomerase is normally active in fetal cells, and then shortly after birth it is turned off in all cells except normal tissue stem cells and some immune cells.
DIET: LOW FOLATE INTAKE LINKED TO GENETIC ABNORMALITIES IN SPERM
Healthy men who report lower levels of the nutrient folate in their diets have higher rates of chromosomal abnormalities in their sperm, according to a new study by researchers at the University of California, Berkeley, and the Lawrence Berkeley National Laboratory. Folate is a water-soluble B vitamin that occurs naturally in a wide range of foods, particularly liver, leafy green vegetables, citrus fruits, and legumes. It is needed during the synthesis of DNA, RNA, and proteins, and it is necessary for the production of new cells. Women of child-bearing age are encouraged to maintain adequate levels of folate in their diet, but the new findings, published in the journal Human Reproduction, provide evidence that what men eat may also affect reproductive health. The researchers said their study is the first to look at the effects of diet on chromosomal abnormalities in sperm. These abnormalities would cause either miscarriages or children with genetic syndromes if the sperm fertilized an egg. An estimated 1 percent to 4 percent of a healthy male's sperm have an abnormal numbers of chromosomes, or aneuploidy, that are caused by errors during cell division (meiosis) in the testis. If these abnormal sperm fertilize a normal egg, there would either be a miscarriage or a fetus with a chromosomal disorder such as trisomy, in which cells have three rather than the normal two copies of a given chromosome. After accounting for factors such as age, alcohol use, and medical history, the researchers found that men reporting the highest intake of folate had 19 percent lower rates of sperm with abnormal numbers of chromosomes than men with moderate folate intake, and 20 percent lower rates compared with men in the low-folate intake group.
Healthy men who report lower levels of the nutrient folate in their diets have higher rates of chromosomal abnormalities in their sperm, according to a new study by researchers at the University of California, Berkeley, and the Lawrence Berkeley National Laboratory. Folate is a water-soluble B vitamin that occurs naturally in a wide range of foods, particularly liver, leafy green vegetables, citrus fruits, and legumes. It is needed during the synthesis of DNA, RNA, and proteins, and it is necessary for the production of new cells. Women of child-bearing age are encouraged to maintain adequate levels of folate in their diet, but the new findings, published in the journal Human Reproduction, provide evidence that what men eat may also affect reproductive health. The researchers said their study is the first to look at the effects of diet on chromosomal abnormalities in sperm. These abnormalities would cause either miscarriages or children with genetic syndromes if the sperm fertilized an egg. An estimated 1 percent to 4 percent of a healthy male's sperm have an abnormal numbers of chromosomes, or aneuploidy, that are caused by errors during cell division (meiosis) in the testis. If these abnormal sperm fertilize a normal egg, there would either be a miscarriage or a fetus with a chromosomal disorder such as trisomy, in which cells have three rather than the normal two copies of a given chromosome. After accounting for factors such as age, alcohol use, and medical history, the researchers found that men reporting the highest intake of folate had 19 percent lower rates of sperm with abnormal numbers of chromosomes than men with moderate folate intake, and 20 percent lower rates compared with men in the low-folate intake group.
HEPATITIS C: PRESIDIO LICENSES PRECLINCIAL PROGRAM IN $108M DEAL WITH XLT BIOPHARMACEUTICALS
San Francisco-based Presidio Pharmaceuticals is licensing XTL Biopharmaceuticals’ pre-clinical program in Hepatitis C. Under the license agreement, Presidio becomes responsible for all further development and commercialization activities and costs relating to the program. XTL, a Rehovet, Israel- based company, will receive an upfront payment of $4 million, and up to an additional $104 million upon reaching certain development and commercialization milestones. In addition, XTL will receive a royalty on direct product sales by Presidio, and a percentage of Presidio's income if the program is sublicensed by Presidio to a third party. The program focuses on the development of novel small-molecule inhibitors against the Hepatitis C virus, and is presently in advanced stages of lead optimization. The current lead compounds target NS5A, a viral protein that is essential for viral production.
NON-SMALL CELL LUNG CANCER: NEREUS INITIATES SECOND EARLY-STAGE CLINICAL TRIAL
San Diego-based Nereus Pharmaceuticals has begun in a Phase 1b study to evaluate the vascular disrupting agent NPI-2358 in combination with standard chemotherapy in patients with non-small cell lung cancer. The study follows on positive outcomes in a Phase 1 single-agent clinical trial assessing the safety, pharmacokinetics, pharmacodynamics, and efficacy of NPI-2358 in various tumor types. The open-label Phase 1b study will assess escalating doses of NPI-2358 in combination with docetaxel in patients with NSCLC who previously failed at least one chemotherapy regimen. The existing preclinical and clinical data suggests that vascular disrupting agents may be complementary or synergistic with chemotherapeutics and anti-angiogenesis agents due to the different targets and mechanisms of action. NPI-2358 has a dual effect on tumors: it selectively attacks existing tumor blood vessels leading to hemorrhagic tumor necrosis without affecting normal vasculature, and it has a direct apoptotic effect on tumor cells.
San Francisco-based Presidio Pharmaceuticals is licensing XTL Biopharmaceuticals’ pre-clinical program in Hepatitis C. Under the license agreement, Presidio becomes responsible for all further development and commercialization activities and costs relating to the program. XTL, a Rehovet, Israel- based company, will receive an upfront payment of $4 million, and up to an additional $104 million upon reaching certain development and commercialization milestones. In addition, XTL will receive a royalty on direct product sales by Presidio, and a percentage of Presidio's income if the program is sublicensed by Presidio to a third party. The program focuses on the development of novel small-molecule inhibitors against the Hepatitis C virus, and is presently in advanced stages of lead optimization. The current lead compounds target NS5A, a viral protein that is essential for viral production.
NON-SMALL CELL LUNG CANCER: NEREUS INITIATES SECOND EARLY-STAGE CLINICAL TRIAL
San Diego-based Nereus Pharmaceuticals has begun in a Phase 1b study to evaluate the vascular disrupting agent NPI-2358 in combination with standard chemotherapy in patients with non-small cell lung cancer. The study follows on positive outcomes in a Phase 1 single-agent clinical trial assessing the safety, pharmacokinetics, pharmacodynamics, and efficacy of NPI-2358 in various tumor types. The open-label Phase 1b study will assess escalating doses of NPI-2358 in combination with docetaxel in patients with NSCLC who previously failed at least one chemotherapy regimen. The existing preclinical and clinical data suggests that vascular disrupting agents may be complementary or synergistic with chemotherapeutics and anti-angiogenesis agents due to the different targets and mechanisms of action. NPI-2358 has a dual effect on tumors: it selectively attacks existing tumor blood vessels leading to hemorrhagic tumor necrosis without affecting normal vasculature, and it has a direct apoptotic effect on tumor cells.
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